Area Quality Specialist

hace 7 días

Santiago de Chile Solventum A tiempo completo

**Area Quality Specialist**

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

As an Area Quality Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

- _Implements procedures of Quality Management Systems related to local requirements and global processes_
- _Determines and disposition critical KPIs (Key Performance Indicators) and dispositions to materials_
- . Perform trainings and qualification to employees_
- . Implement and maintain ISO9001/13485 certification to the site_
- . Support product releases and certificate of analysis monitoring and downloading_
- _Supports daily routine of product manintenance activities; shelf-life monitoring and providing product certificates to customers and for product releases_
- _Monitor compliance to local regulatory requirements and attend audits_
- _Leads improvement on Good Warehouse and Distribution Practices including supplier improvements/3PLs_

**Your Skills and Expertise**

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

- Bachelor’s degree or higher as Engineer or Health Care related profile
- Three (3) years of experience in quality related activities
- Intermediate to advanced English

Additional qualifications that could help you succeed even further in this role include
- Statistics background
- ISO9001 and/or ISO13485 knowledge
- Skills include good team building; critical mindset on regulatory attributes; risk escalation perceptiveness; problem solving
- Knowledge of regulation of Good Storage, Distribution, Warehousing, Transportation Practices of Medical Devices and/or Drugs.

**Work location**:

- **Hybrid (Solventum office and 3PL warehouse when necessary for task deliverables)**

**Travel: May include up to 10% in country**

**Relocation Assistance: No**

**Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).**

Solventum es un empleador que ofrece las mismas oportunidades. Solventum no discriminará a ningún solicitante de empleo por razones de raza, color, edad, religión, sexo, orientación sexual, identidad o expresión de género, origen nacional, discapacidad o estado de veterano.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

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